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510(k) Data Aggregation

    K Number
    K210126
    Device Name
    Sodium Chloride Inhalation Solutions, 3%, 3.5%, 7% and 10%
    Manufacturer
    The Ritedose Corporation
    Date Cleared
    2021-12-03

    (318 days)

    Product Code
    CAF
    Regulation Number
    868.5630
    Why did this record match?
    Applicant Name (Manufacturer) :

    The Ritedose Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Sodium Chloride Inhalation Solution, USP is used in conjunction with a nebulizer. The contents of the induction of sputum production where sputum production is indicated. Concentrations of 3%, 3.5%, 7%, and 10%.
    Device Description
    The proposed device is a sterile, preservative-free Sodium Chloride Inhalation Solution, USP, provided in concentrations of 3%, 3.5%, 7%, and 10% with a nominal fill volume of 4 mL and supplied in single-use low density polyethylene (LDPE) vials.
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